Drug factory · FDA FEI 3006441845
Diamond Respiratory Care, Inc.
1403 Palmyrita Ave, Riverside, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 18, 2014.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2014: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Diamond Respiratory Care, Inc. | 40097-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 18, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 18, 2014 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit. - Lot or control number assigned 21 CFR 211.130(c)
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. - Expiration date lacking 21 CFR 211.137(a)
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance. - Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt, identification, storage, sampling, and testing of components. - Identity Testing of Each Component 21 CFR 211.84(d)(1)
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
Registered with FDA for: manufacture.